The drug delivers fentanyl through the mouth’s mucous membranes via an absorbable film that sticks to the inside of the cheek. Because fentanyl is an opioid subject to abuse and misuse, the agency approved Onsolis with a risk-evaluation and mitigation strategy, or REMS, a required plan for managing risks associated with a drug.

“Onsolis can provide strong pain relief to patients who are opioid-tolerant,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said in a statement. “But for patients who are not opioid-tolerant, it can lead to overdose, sudden serious breathing difficulties and death.”

Experts discuss medication adherence

WASHINGTON Poor adherence to medication regimens could counteract the benefits of healthcare reform, a panel of experts concluded Wednesday.

The panel — which brings together experts from GlaxoSmithKline, the National Association of Chain Drug Stores Foundation, the National Consumer’s League and the Pharmaceutical Research and Manufacturers of America — hopes to open a dialogue about medication adherence with between experts from the health, medical, insurance, business, employer, academic and government sectors.

“To date, medication adherence hasn’t been a prominent part of the debate,” conference moderator and founding editor of the journal Health Affairs John Iglehart said in a statement. “But no matter what shape health reform takes, it will ultimately be more successful if it supports the education and motivation of patients to properly follow their medication regimens.”

Participants in the panel will receive briefings on two new research efforts on medication adherence conducted by Avalere Health and the RAND Corp., respectively, using findings from the studies to guide the creation of policy and public education recommendations.

As many as 80% of patients may not be adhering to their medication regimens, according to research, resulting in adverse consequences and draining $100 billion to $300 billion from the healthcare system every year.

MiddleBrook Pharmaceuticals develops copay program for Moxatag

WESTLAKE, Texas A company making a long-acting formulation of a common antibiotic has announced a program to minimize the drug’s cost to consumers.

MiddleBrook Pharmaceuticals announced Wednesday a $20 maximum copay program for Moxatag (amoxicillin) extended-release tablets in the 775 mg strength, designed to keep the drug’s cost to patients at $20 or less. The company said it will field 300 representatives and district managers to begin supplying physicians with voucher cards for the program.

“In this tough economy, we recognize the need to improve Moxatag’s affordability to the patient,” MiddleBrook president and CEO John Thievon said in a statement. “This $20 maximum copay program will replace our current $15 point-of-sale copay check program, which has been in place since Moxatag’s launch.”

RELATED NEWS

The Food and Drug Administration has approved a generic of Hoffman-La Roche’s Tamiflu (oseltamivir phosphate) capsules from Lupin. The company’s generic will be available in 30-, 45- and 75-mg dosage strengths.
The product is inficated to treat acute, uncomplicated influenza A and B in patients 2 weeks of age and older, as well as to prevent influenza A and B in patients 1 year old and older. The drug had U.S. sales of roughly $467.8 million for the 12 months ended October 2017, according to IQVIA data.

Behavioral health pharmacy and telepsychiatry company Genoa, a QoL Healthcare Company, has reached a big number with its remote psychiatry offering. The Tukwila, Wash.-based company announced Tuesday that it had facilitated more than 100,000 telepsych consultations on its video conferencing platform.
Genoa attributes the milestone to its recent buildup of its telepsychiatry operations, which grew to include 35 in 2017 from 20 at the start of the year, and included 250 providers. In 2017, the company grew to serve more than 2,500 patients per week.

This year's flu continues to be Texas big, according to the Walgreens Flu Index released Wednesday, as the top 10 communities experiencing the greatest amount of flu incidence were all located in the Lone Star State for the week ended Jan. 6.
Iowa, Idaho and Arkansas rank behind Texas in terms of flu activity. And Montana, Idaho and Iowa ranked highest among states experiencing flu activity gains.

Amneal Biosciences has launched its generic of Otsuka’s Busulfex (busulfan injection, 6 mg/ml). The product is indicated to treat chronic myelogenous leukemia.
Amneal said that its generic is available in cartons of eight single-dose vials, each of which contains 60 mg of the drug in a 10-ml clear sterile solution. The product is made without natural rubber, latex, gluten or preservatives, Amneal said.
The drug had U.S. sales of roughly $80 million for the 12 months ended October 2017, according to data from IQVIA.

Amneal Pharmaceuticals has launched sevelamer carbonate tablets, 800 mg, in 270-count bottles. This generic from the Bridgewater, N.J.-based company is an AB-rated therapeutic equivalent to Renvela.
Amneal also launched five other products in addition to sevelamer carbonate:

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